Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION (x)

• ClinicalTrials.gov Identifier: NCT04629066
• Recruitment Status: Completed
• First Posted: November 16, 2020
• Last Update Posted: June 23, 2022
• Sponsor: Duke University
• Collaborators: NESTcc; MDIC
• Information provided by (Responsible Party): Duke University

Study Description

Brief Summary:

This single center randomized controlled trial will involve 50 medically stable outpatients with HF, reduced ejection fraction, and previously implanted ICD or CRT-D devices followed longitudinally on the Abbott Medical Merlin remote patient monitoring network. Patients will be randomized in a 1:1 fashion to usual care plus a remotely administered home based weekly prescription for aerobic exercise (intervention) or usual care alone (control). Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team. The exercise prescription will be created by an exercise physiologist after incorporating remotely collected data from a patient directed smartphone app assessing HF symptom severity, vital signs, weight, and blood sugar, implantable device measures of physical activity, heart rate, heart failure volume status and heart rhythm, and Fitbit measures of physical activity.

Condition or disease	Intervention/treatment	Phase
Heart Failure	Behavioral: Remote Cardiac Rehabilitation (CR)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION (Pilot Randomized Controlled Trial)
• Actual Study Start Date: April 27, 2021
• Actual Primary Completion Date: March 15, 2022
• Actual Study Completion Date: March 15, 2022

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Usual care; Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team.
Experimental: Remote prescription for aerobic exercise; The exercise prescription will be created by an exercise physiologist after incorporating remotely collected data from a patient directed smartphone app assessing HF symptom severity, vital signs, weight, and blood sugar, and cardiac implant measures of physical activity, heart rate, heart failure volume status and heart rhythm, and Fitbit measures of physical activity.	Behavioral: Remote Cardiac Rehabilitation (CR); Patients randomized to remote CR will be asked to use an app for cardiac rehabilitation a minimum of 3 times a week. Patients will be given an exercise prescription provided by a certified exercise physiologist. The exercise prescription will change each week based on refreshed data from the prior week. Instructional videos for each exercise are provided in the app. Patients will not be told to perform the exercise at a particular time. Instead they will be asked to complete a certain amount of exercise per week at whatever time is convenient for them. Patients randomized to remote CR will also receive App based reminders to take their medications, resources to guide healthy eating habits, and other behavioral health advice as is done as standard of care in both remote based and clinic based CR.

Outcome Measures

Primary Outcome Measures :

1. Abbott ICD and CRT-D device measured daily PA [ Time Frame: 12 weeks after randomization ]
   mean Abbott ICD and CRT-D device measured daily PA
2. HF symptom severity scores [ Time Frame: 12 weeks after randomization ]
   Kansas City Cardiomyopathy Questionnaire (KCCQ) HF symptom severity scores
3. daily step counts [ Time Frame: 12 weeks after randomization ]
   change in mean Fitbit measured daily step counts from baseline
4. frequency of the combination of heart failure hospitalization, fracture, myocardial infarction, serious adverse arrhythmia, and ICD therapy [ Time Frame: Cumulative during 12 weeks of intervention ]
5. change in daily Physical Activity [ Time Frame: 12 weeks after randomization ]
   change in daily PA measured by the Abbott ICD or CRT-D device
6. change in KCCQ HF symptoms severity score [ Time Frame: 12 weeks after randomization ]
7. correlation between the change in daily step count and change in HF symptoms severity score [ Time Frame: 12 weeks after randomization ]
   correlation between the change in daily step count measured by the Fitbit device and change in KCCQ HF symptoms severity score

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients have a MERLIN patient registry record for an ICD or CRT-D implantation between 01/01/2010-12/31/2020
• Age > 18 years
• Left ventricular ejection fraction < 50% by echocardiogram, nuclear cardiology scan, cardiac magnetic resonance imaging, or invasive left ventriculography within the past 12 months.
• Ongoing NYHA class II, III, or IV HF symptoms by questionnaire
• Ongoing use of beta-blocker and ACE-inhibitor or angiotensin receptor blocker or willingness to start them- assessed by Duke Epic EMR screening.
• Life expectancy > 12 months
• To allow for a post-surgical adjustment period, patients must be >30 days out from device implantation

Exclusion Criteria:

• Prior participation in CR- by patient questionnaire
• Unwillingness to sign informed consent form
• Currently performing > 240 minutes of device detected daily PA- by ICD/CRTD remotely collected data.
• Lack of a smartphone or unwillingness to use an App or Fitbit device
• Prior left ventricular assist device (LVAD) implantation or heart transplantation
• ICD tachyarrhythmia therapies programmed off
• Inherited arrhythmia condition with contraindication to exercise (eg Lamin A mutation or ARVC)
• No transmissions through Merlin.net in past 12 months

Contacts and Locations

Locations

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

NESTcc

MDIC

Investigators

• Principal Investigator: Brett Atwater, MD; Duke University

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04629066
• Other Study ID Numbers: Pro00107053
• First Posted: November 16, 2020
• Last Update Posted: June 23, 2022
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:

Remote Exercise Prescription; Cardiac Implant

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases